N-acetyl-cysteine and Carbohydrate Metabolism Disorder in Obese Women

NCT ID: NCT03902327

Last Updated: 2020-03-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-17

Study Completion Date

2020-12-31

Brief Summary

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The effect of N-acetylcysteine supplementation on carbohydrate metabolism disorder and homocysteine concentrations in obese women will be analysed.

Detailed Description

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Conditions

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Insulin Resistance Obesity Carbohydrate Metabolism Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized Controlled Trails
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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NAC group

NAC for 12 weeks, 1.6 mg/day, 4x400 mg; a diet based on general recommendations for people with carbohydrate metabolism disorder

Group Type EXPERIMENTAL

NAC group

Intervention Type DIETARY_SUPPLEMENT

Nutrition intervention focused on the treatment of carbohydrate metabolism disorder + N - acetylocysteine supplementation (1600 mg /d, 400 mg x 4 times a day)(30 people).

Control group

Placebo for 12 weeks and a diet based on general recommendations for people with carbohydrate metabolism disorder

Group Type ACTIVE_COMPARATOR

Control group

Intervention Type DIETARY_SUPPLEMENT

Nutrition intervention focused on the treatment of carbohydrate metabolism disorder + placebo (4 times a day) (30 people).

Interventions

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NAC group

Nutrition intervention focused on the treatment of carbohydrate metabolism disorder + N - acetylocysteine supplementation (1600 mg /d, 400 mg x 4 times a day)(30 people).

Intervention Type DIETARY_SUPPLEMENT

Control group

Nutrition intervention focused on the treatment of carbohydrate metabolism disorder + placebo (4 times a day) (30 people).

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* women diagnosed with carbohydrate metabolism disorder,
* obesity (BMI \>29,9 kg/m2)
* patients not participating in other similar research programs at the same time,
* written agreement to take part in the research.

Exclusion Criteria

* the use of medicament that may affect on carbohydrate metabolism within 4 weeks,
* failure to comply with dietary recommendations established during the nutritional intervention,
* pregnancy and breast feeding.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Poznan University of Life Sciences

OTHER

Sponsor Role lead

Responsible Party

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Agata Chmurzyńska

dr hab, Director of Institute of Human Nutrition and Dietetics

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Poznan University of Life Sciences

Poznan, , Poland

Site Status RECRUITING

Countries

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Poland

Facility Contacts

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Karolina Łagowska, PhD

Role: primary

+48618487335

Other Identifiers

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PoznanULS

Identifier Type: -

Identifier Source: org_study_id

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